LabCorp Announces the Availability of Hepatitis C Virus Q80k Polymorphism Screening for the Newly Approved Drug OLYSIO™

  LabCorp Announces the Availability of Hepatitis C Virus Q80k Polymorphism
  Screening for the Newly Approved Drug OLYSIO™ (simeprevir)

Business Wire

BURLINGTON, N.C. -- December 3, 2013

Laboratory Corporation of America^® Holdings (LabCorp^®) (NYSE: LH) announced
today the immediate availability of an enhanced version of its HCV GenoSure^®
NS3/4, a drug resistance test that screens for the Q80K polymorphism. Q80K is
a naturally occurring polymorphism that develops in certain strains of HCV,
making the virus less susceptible to Janssen Therapeutics’ OLYSIO™
(simeprevir), which was recently approved by the U.S. Food and Drug
Administration for the treatment of certain adult patients diagnosed with
genotype 1chronic hepatitis C (HCV). In clinical trials, patients with HCV
genotype 1 containing the Q80K polymorphism demonstrated significantly lower
response rates to treatment with OLYSIO. Approximately one-third of HCV
patients have virus with Q80K polymorphism. Given the high frequency of the
Q80K polymorphism and its significant impact on OLYSIO’s success rate, it is
recommended that patients be screened for the Q80K polymorphism prior to
treatment.

LabCorp and Monogram Biosciences, Inc., a member of the LabCorp Specialty
Testing Group, were the first to launch an HCV drug resistance test for NS3/4A
protease inhibitors. In addition to OLYSIO, LabCorp’s HCVGenoSure NS3/4A test
also provides resistance information for the drugs VICTRELIS^® (boceprevir)
and INCIVEK^®(telaprevir). With the inclusion of all three FDA approved
protease inhibitors, HCV GenoSure NS3/4A enables healthcare providers to
select the most appropriate therapy regimen for their patients.

An estimated 3.2 million people in the U.S. (and 170 million worldwide) are
chronically infected with HCV, which if left undiagnosed and untreated can
lead to liver fibrosis, cirrhosis and hepatocellular carcinoma. The Centers
for Disease Control and Prevention (CDC) estimates that nearly half of the
U.S. HCV population is currently undiagnosed, and the slow and often silent
onset of HCV disease presentation has prompted more aggressive efforts to
proactively diagnose and treat HCV infection. “We are proud to be a leader in
the growing effort to screen and monitor individuals with HCV and to support
physicians in treatment decisions to improve patient outcomes,” said David P.
King, Chairman and CEO.

About LabCorp^®

Laboratory Corporation of America^® Holdings, an S&P 500 company, is a pioneer
in commercializing new diagnostic technologies and the first in its industry
to embrace genomic testing. With annual revenues of $5.7 billion in 2012, over
34,000 employees worldwide, and more than 220,000 clients, LabCorp offers more
than 4,000 tests ranging from routine blood analyses to reproductive genetics
to companion diagnostics. LabCorp furthers its scientific expertise and
innovative clinical testing technology through its LabCorp Specialty Testing
Group: The Center for Molecular Biology and Pathology, National Genetics
Institute, ViroMed Laboratories, Inc, The Center for Esoteric Testing,
Litholink Corporation, Integrated Genetics, Integrated Oncology, Dianon
Pathology, Monogram Biosciences, Inc, Colorado Coagulation, Cellmark
Forensics, MedTox, and Endocrine Sciences. LabCorp conducts clinical trials
testing through its LabCorp Clinical Trials division. LabCorp clients include
physicians, government agencies, managed care organizations, hospitals,
clinical labs, and pharmaceutical companies. To learn more about our
organization, visit our website at: www.labcorp.com.

OLYSIO is a trademark of Janssen Therapeutics, Division of Janssen Products,
LP.

VICTRELIS is a registered trademark of Schering Corp., a subsidiary of Merck &
Co., Inc.

INCIVEK is a registered trademark of Vertex Pharmaceuticals Incorporated.

This press release contains forward-looking statements. Each of the
forward-looking statements is subject to change based on various important
factors, including without limitation, competitive actions in the marketplace
and adverse actions of governmental and other third-party payors. Actual
results could differ materially from those suggested by these forward-looking
statements. Further information on potential factors that could affect
LabCorp’s financial results is included in the Company’s Form 10-K for the
year ended December 31, 2012, and subsequent SEC filings.

Contact:

Laboratory Corporation of America^® Holdings
Stephen Anderson, 336-436-5076
www.labcorp.com
 
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